Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin.

It had two arms (groups): Farxiga with metformin or insulin (experimental) and Placebo with metformin or insulin (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin.

Who Took Part

The registry lists 226 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 diabetes mellitus (T2DM). Body mass index (BMI) \< or = to 45 kg/m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: use of sulfonylureas during the 8 weeks prior to screening; prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (sglt-2) inhibitor; ingestion of any medication know to affect glucose metabolism for \>7 consecutive days during the 3 months prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2015-05 with completion listed for 2015-10.

It ran at 26 sites in United States (26).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System (time frame: Baseline to Week 4).

It also tracked 10 secondary outcomes, for example Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4, Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4, Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4, Change in HbA1c From Baseline to Week 4, Change in Fructosamine From Baseline to Week 4 and Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 226 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.